MethOxyflUraNe at moderaTe High AltItudes for PAIN Management (MOUNTAIN-PAIN)

University of Cape Town (UCT)

Status and phase: Unknown; Phase 4

Conditions: Pain

Treatments: Drug: Methoxyflurane; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT03849027

MOUNTAIN-PAIN

Details and patient eligibility

About

A randomised, double-blind, cross-over study to assess the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting.

Phase IV, randomised, double-blind, cross-over clinical trial to evaluate the analgesic effect of methoxyflurane at moderate high altitudes in a wilderness field setting, in 24 healthy volunteers

Full description

Primary outcome: To assess the analgesic efficacy of inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Secondary outcomes: To assess the comparative safety and adverse events with inhaled methoxyflurane at moderate high altitudes in a wilderness setting.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Male or female between 18 and 65 years of age (inclusive).
2. Able to provide informed consent and comply with study-related procedures

Exclusion criteria

1. History of diabetes
2. Renal or hepatic disease or impairment (defined as a value exceeding the maximum reference range)
3. Chronic or nociplastic pain
4. Chronic fatigue syndrome
5. Chronic/regular use of analgesic medications
6. Personal or familial history of malignant hyperthermia
7. Personal or familial history of anaesthesia-induced rhabdomyolysis
8. Personal history of anaesthesia volatile-induced hepatitis or drug induced liver injury
9. Recent volatile anaesthesia (within 6 months)
10. History of significant altitude-related illness
11. Significant underlying medical condition which precludes gentle exercise at moderate high altitude (<2500 m ASL) as determined by the investigators
12. Hypersensitivity to Penthrox/Penthrop®, methoxyflurane or any fluorinated anaesthetic.
13. Concurrent treatment with CYP 2A6 or CYP 2E1 enzyme inducers (such as: phenobarbital, rifampicin, alcohol or isoniazid)
14. Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

24 participants in 2 patient groups

Methoxyflurane

Experimental group

Description:

Inhaled methoxyflurane once-off dose of 3 ml will be administered via the inhaler at each dosing visit . Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®).

Treatment:

Drug: Methoxyflurane

Sham Methoxyflurane

Sham Comparator group

Description:

The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test

Treatment:

Drug: Placebo